1. Field of the Invention
This invention relates to the general field of medical devices. The invention particularly relates to a device and method for holding medical tubes, balloons and the like (hereinafter "implements") in place adjacent the mouth, nose or other orifice of a medical patient. The invention is best suited for keeping such implements in place with substantially permanent traction. The invention provides novel means for holding such implements in position while allowing for adjustment of the amount of traction to be placed thereon.
2. Technology Review
Numerous medical tube holders have been designed and patented over the past forty years. Very few allege to possess any traction-imparting abilities, however. U.S. Pat. No. 2,669,231 claims an anchor construction for removably retaining flexible tubes without constricting said tubes. The anchor construction consists of a sponge rubber, yieldable pad adhesively mounted to a woven cotton strip. The outer edges of this strip are provided with metal eyelets for stringing a fastening line therethrough.
In U.S. Pat. No. 2,898,917, the catheter or drainage tube holder that is disclosed consists of a one-piece, rubber latex retention disk secured to the patient's skin with a surgical adhesive. The disk portion of this holder conforms to the surface of the body being treated.
U.S. Pat. No. 3,046,988 claims an improved esophageal, nasogastric tube similar to the type of balloon/catheter systems most commonly employed with the present invention. A part of this prior art tube comprises a nasal cuff preferably constructed of non-toxic sponge foam. The cuff includes a bore that extends completely through, said bore connecting to an outer edge of the cuff via slot 60 in FIG. 5. Although this cuff alleges to provide some traction, it is this inventor's experience that the traction provided by such a spongelike cuff is inconsistent, unpredictable and rather short-lived. As these cuffs absorb moisture from the patient's nose or mouth, they loosen their grip on the tubes passing therethrough.
The nasal tube holder of U.S. Pat. No. 3,046,989 consists of a thin, ductile sheet of aluminum to which is adhesively mounted a plastic-coated paper or other protective sheath for sanitation, storage and handling purposes. The tube holding portion of said invention comprises a tab from the aluminum sheet for wrapping about the patient's nasal tube.
U.S. Pat. No. 3,286,713 addresses surgical dressing made from folded sheets of absorbent material, said sheets having a pair of spaced apart apertures through which a tubular object passes. This dressing allegedly frictionally engages with the tube by gripping thereon to avoid any need for surgical adhesives.
An endotracheal tube holder is shown in U.S. Pat. No. 3,946,742. This tube holder comprises an open-sided retainer 24 fixedly mounted to the upper end of an arm pivotally pinned to a plastic strap 14 for securing about the neck of a patient. U.S. Pat. No. 3,976,080 claims an alternate tube holder, also strapped about the patient's head using slots 28, said tube holder including a frame-mounted projection upon which the tube rests, and a pair of opposing tabs for serving as stop lugs.
In the nasogastric tube holder of U.S. Pat. No. 4,120,304, a clamp portion 4 comprises a rigid, generally circular disk having a hole and slot cut therethrough. Although this clamp is necessary to the remainder of this prior art tube holder as shown, it does not contact with the patient's nose and cannot provide any traction to the tube being held in place therewith.
U.S. Pat. No. 4,142,527 shows yet another variation of endotracheal tube holder, which variation employs an adhesive-backed strip portion for securing a tube holding portion to the patient's nose. The tube holding portion includes a section of Velcro (or hook and eye interlocking) tape.
In U.S. Pat. No. 4,261,363, there is claimed a retention clip for body fluid drains. The upper portion of this clip is longitudinally slotted for sideways insertion of a drain there-through. The base portion of this clip may be taped or otherwise secured to the patient's body. Preferred embodiments of this clip are made from semi-resilient material such as polyvinyl chloride.
The medical tube holder of U.S. Pat. No. 4,336,806 comprises a generally rectangular backing strip made from a porous foam plastic material. A plurality of magnets are laminated onto the inner surface of this backing strip for securing to one another about the medical tube being held in place when the backing strip is folded onto itself.
U.S. Pat. No. 4,392,857 claims a tube clamp whose length-wise base lies disposed along a section of tube with a U-shaped strap retainer fixed to this base, a strap fixed to one end of the base, at least one side of said strap and one arm of the retainer having complementally-formed triangular slots. A lower side of this clamp includes pressure sensitive adhesive for securing to a patient's skin.
The tube retaining device of U.S. Pat. No. 4,480,639 comprises a flexible strap with first clamp means for positioning beneath a patient's nose, and second clamp means near one end of the strap for holding the tube in a fixed position adjacent the patient.
There is claimed an endotracheal tube holder in U.S. Pat. No. 4,683,882. This tube holder includes a base for supporting an adhesive strap that secures the holder about the mouth of a patient. An adjustable clamp releasably secures a tube through a central opening in this base, said clamp being either a gate-type, C-clamp or notched strap type.
U.S. Pat. No. 4,520,813 shows yet another form of endotracheal tube holder within a pair of identical, curved plate-like hooking members, each with a dogleg opening, interconnect about the tube before being attached about a patient's neck or face with Velcro bands.
In U.S. Pat. No. 4,606,735, a detachable medical tube holder is described. This tube holder is formed from a flexible plastic strip having upstanding end wings, each of which is provided with a pair of snap-in keyhole slots in axial alignment with one another. It is secured to a patient's skin using male and female Velcro tape fasteners.
The medical tube holder of U.S. Pat. No. 4,622,034 consists of a multi-apertured foam strip for wrapping about the head of a patient and inserting a tracheal or nosogastric tube through any two aligned holes on opposite ends of the strip. An alternate embodiment employs Velcro fastening means.
U.S. Pat. No. 4,844,061 shows a medical tube holder that includes an elongated strip of resilient fabric with porous foam bonded thereto. At one end of this strip, an aperture fits over a portion of the medical tube extending outwardly from the patient's mouth. A thin piece of adhesive wraps about the tube before securing to itself to form a ring about the tube.
Still other tube holders are set forth in U.S. Pat. Nos. 4,867,154, 4,906,234, 4,959,055, 5,009,227, 5,017,188, 5,027,188, 5,026,352 and 5,031,775.